The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Infinity Total Ankle System.
Device ID | K181557 |
510k Number | K181557 |
Device Name: | INFINITY Total Ankle System |
Classification | Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer |
Applicant | Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 |
Contact | Tara Conrad |
Correspondent | Tara Conrad Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 |
Product Code | HSN |
CFR Regulation Number | 888.3110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-06-13 |
Decision Date | 2018-08-09 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00889797069700 | K181557 | 000 |
00889797069694 | K181557 | 000 |
00889797069687 | K181557 | 000 |
00889797069670 | K181557 | 000 |
00889797069663 | K181557 | 000 |
00889797069656 | K181557 | 000 |
00889797069632 | K181557 | 000 |